Company:Becton Dickinson & Co..
Date of Enforcement Report 6/6/12
Class ll:
PRODUCT
1) Becton Dickinson Phoenix” System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: Automated Microbiology System for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Positive bacteria from pure culture. Recall # Z-1657-2012;
2) Becton Dickinson Phoenix” Update Disks (PUD), catalog # 441107/ 448047, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: This update disk was an interim corrective action recommended by FDA to be installed in Phoenix instruments so that test results associated with E.faecium susceptibility can not be printed by the labs until a final algorithm correction (change) is implemented by the firm. BD Phoenix” Update Disks (PUD). Recall # Z-1658-2012
REASON
In vitro diagnostics manufacturer identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all PMIC or PMIC/ID panels and could lead to ineffective treatment regimen in affected patients.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., Sparks, MD, by letter dated April 18, 2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3,454,993 units
DISTRIBUTION
Nationwide and Internationally
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